Aliskiren and Renin Inhibition in Diastolic Heart Failure

NCT ID: NCT00773084

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-08-31

Brief Summary

This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.

Detailed Description

Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.

Conditions

Diastolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Group Type: ACTIVE_COMPARATOR

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Intervention Type: DRUG

Subjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed.

Interventions

Aliskiren plus spironolactone vs. Lisinopril plus spironolactone

Subjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed.

Intervention Type: DRUG

Other Intervention Names

Tekturna; Lisinopril; Spironolactone

Eligibility Criteria

Inclusion Criteria

1. Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years

2. NYHA classes I-III, symptomatically stable (for >1month)

3. Age 21-70 years

4. Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white

5. Patients on ACE inhibitor therapy (lisinopril)

6. Blood pressure >100/75 mmHg

7. Adequate birth control

8. Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two visits since January 2008

Exclusion Criteria

1. Acute coronary syndrome (within the last month).

2. Recent acute diastolic or systolic HF (within the last month)

3. Pancreatic disease

4. Renal artery stenosis

5. Pregnancy

6. History of angioedema

7. Severe hypotension (systolic BP<90mmHg or mean arterial pressure <65mmHg)

8. Hyperkalemia (defined by K+>5 mEq/L)

9. Chronic Kidney Disease (Stage 3 and above)

10. Systolic dysfunction (ejection fraction below 50%)

11. Ethnicity other than Mexican American or non-Hispanic white

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Texas Tech University Health Sciences Center--Dept. of Internal Medicine

Locations

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Countries

United States

Other Identifiers

ARID-HF

Identifier Type: -

Identifier Source: org_study_id